Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-10-31

Brief Summary

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This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

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Detailed Description

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Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intranasal Application

Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Group Type EXPERIMENTAL

Intranasal Tear Neurostimulator

Intervention Type DEVICE

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Extranasal Application

Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Group Type SHAM_COMPARATOR

Intranasal Tear Neurostimulator

Intervention Type DEVICE

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Interventions

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Intranasal Tear Neurostimulator

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe dry eye disease
* Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
* Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
* Corneal transplant in either or both eyes
* A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No